the opportunity to also ensure profile accuracy when adjusting the patients’ billing information. Is the patient’s address and phone number up to date? Do they have any allergies you may not have listed? Since a pharmacy employee is already in their profile adjusting the insurance information, it may be beneficial to verify that the demographics on file are still accurate.

While it is important to have current information for purposes of patient safety and accuracy, it’s also a requirement for some PBMs. Section 10.08 of Caremark’s Provider Manual highlights this requirement for maintaining up to date Part D patient information on their profiles. Often during an on-site visit, Caremark auditors will ask to see a covered Part D patient’s profile, looking specifically for patient demographics and allergy information. While PAAS National^® has not seen any significant recourse due to missing information on Part D patient profiles, consider validating these elements when updating insurance information.  

New Year also means new formularies! Be cautious of incoming refills utilizing a DAW 9 as a new formulary could require the generic or a different drug entirely. PAAS suggests challenging a historical DAW 9 (by trying to bill the claim with the generic) with any new plan year, change in insurance or new prescription being authorized.

PAAS Tips:

• Be on the lookout for person codes or insurance cards with patient specific ID numbers
• If a claim is rejected due to a mismatch in the patient’s date of birth submitted on the claim (versus the date of birth on file with the insurance company), call the patient to verify the correct date of birth.
  • If your system is correct and the insurance plan has documented the incorrect date of birth, be sure the patient contacts their plan (or Human Resources Department for employee-sponsored plans) and updates their information.
  • Changing the date of birth in your system to be incorrect (but match the PBM) is not advisable and can lead to dispensing errors and future claim issues.
• If you see a blank field in the allergies section of a patient’s profile, confirm allergy information with the patient and update their file accordingly.
• If your system has “no known allergies” listed for a patient, periodically verify that this is still accurate, as some patients develop allergies and sensitivities to medications, ingredients and foods as they age.
• Be sure to include not only food allergies, but allergies to dyes as well. Some examples are as follows:
  • Progesterone capsules can be made using peanut oil
  • Some flu shots may not be appropriate for patients with egg allergies
  • Many medications have dyes in them to produce their coloring
  • Gelatin allergy is crucial to document on a patient’s file, as many capsules are composed of gelatin

billing and dispensing the same NDC, down to the correct package size.  

Unit-of-use packages like test strips, inhalers, and topical medications are some of the biggest culprits. PBMs flag claims for these products when the billed quantity is not divisible by the package size billed, making them low-hanging fruit to PBMs looking for recoupments. Pharmacies also need to be cautious of dispensing multiples of smaller package sizes when a larger package size is available on the market.

On desk or onsite audits where the auditor is conducting prescription reviews, recoupment for these claims can vary depending on the PBM and situation. Some scenarios might call for a partial recoupment with the PBM indicating they will pay for the correct package size. However, more precarious situations could seek full recoupment with little room for appeal. Listed below are common scenarios to be on the lookout for:

• Billing 28 g on a topical with a package size of 30 g
• Dispensing two 30 g tubes when a 60 g package size is available
• Billing an NDC for a 100-count box of test strips with a quantity of 150
• Billing the institutional NDC for Symbicort^® with a quantity of 10.2 g

In the case of invoice audits, the auditor will be looking at the pharmacy’s invoices to ensure the exact NDC # that was billed matches what NDC # was received by the pharmacy as reflected on the wholesaler invoice. PAAS National^® has many Newsline articles to help your pharmacy be prepared for an invoice audit, the most recent article being part of the Self-Audit Series.    

PAAS Tips:

• Implement barcode scanner technology for product verification to prevent misfills and ensure filling/billing accuracy
• Verify the quantity billed matches tube size dispensed for topical medications (when feasible and appropriate). Often, the last 2 digits of the NDC match the package size
• If you need to dispense two smaller package sizes because the larger package size is unavailable/backordered, document accordingly (e.g., urgent clinical need or proof from your wholesaler that the larger package size was unavailable and attach it to the prescription)
  • Alternatively, contact the prescriber to modify the quantity prescribed and refills to match available package sizes
• Flag shelves for medications with multiple package sizes to remind staff to doublecheck the NDC

stay informed about these changes. CMS released two helpful guidance documents: the PrEP for HIV National Coverage Determination (NCD) Technical Frequently Asked Questions for Pharmacies and the Fact Sheet: Medicare Part B Coverage of Pre-exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention. Below is a summary of the guidance provided in these two CMS documents.

First, the pharmacy must be enrolled as a Part B pharmacy supplier or as a DMEPOS supplier to bill Medicare Part B for HIV PrEP medications. If your pharmacy is not currently enrolled as a supplier, but you wish to take the steps to become enrolled, CMS recommends enrolling as a Part B pharmacy supplier since there is a “lower burden of enrollment” and revalidation does not occur as frequently for a Part B pharmacy supplier compared to a DMEPOS supplier. More information about enrollment can be found by going to the PrEP for HIV & Related Preventative Services CMS webpage and clicking on “How Do I Enroll”.

Second, pharmacies must submit a valid diagnosis code (ICD-10) on the HIV PrEP claim. Below is a table of diagnosis codes that may be appropriate.

Third, the following are expectations of the dispensing pharmacy:

1. Have and maintain the order from the ordering physician or non-physician practitioner.
2. Obtain the diagnosis code from the ordering practitioner.
3. Have and maintain proof of delivery (i.e., a signed receipt or some other indication the item was dispensed to the beneficiary).
4. The date the claim is billed should match the date of dispensing, defined as the date the drug is picked up from the pharmacy or date drug is mailed.
5. Bill either a 30, 60, or 90 days’ supply and bill the appropriate corresponding HCPCS code.
6. No modifiers are required on the HIV PrEP claims (see PAAS Tips for 340B claims).

Fourth, “the supply fee must be billed on the same claim as the PrEP for HIV drug”. This means, the pharmacy will bill the drug fee as well as the supply (“dispensing”) fee; both claims should be billed with the same date of service, diagnosis code, place of service, etcetera. If your pharmacy utilizes a Medicare Part B billing intermediary, the dispensing fee claim will likely be taken care of by the intermediary on behalf of the pharmacy. If the PrEP drug (e.g., cabotegravir) is being delivered to a medical practice for administration, the date of service billed should match the date of service delivered to the medical office. The medical office would then bill Medicare separately for the administration fee once they administer the medication to the patient. The date of service on the administration fee claim from the medical practice does not have to match the date of service on the pharmacy’s drug and supply fee claims.

Fifth, Medicare Part B claims must be submitted with the name and NPI number of the enrolled ordering/referring practitioner and the name and NPI of that practitioner must appear in the CMS Order and Referring dataset. Since pharmacists do not currently appear in this dataset, they are not eligible for ordering PrEP drugs for payment under Medicare Part B. Therefore, “if a pharmacist, under state scope of practice laws, furnishes counseling, injects a PrEP drug or orders PrEP, those series cannot be paid directly to the pharmacy and the drugs cannot be paid by Medicare Part B. Pharmacists may provide, when all conditions are met, service as auxiliary personnel “incident to” a physician’s or other practitioner’s service in certain settings. The incident to regulations require supervision by a physician or other practitioner, and such services would be billed by the supervising physician or practitioner.” Additional information about “incident to” services can be found under 42 CFR §§410.26 and 410.227 or visit the Incident To Services & Supplies CMS webpage.

PAAS Tips:

• Ensure these HIV PrEP medications are returned with a $0 copay from in-network pharmacies as of September 30, 2024
• Pharmacies not enrolled as a DMEPOS supplier or Medicare Part B Pharmacy supplier can refer individuals to 1-800-MEDICARE (1-800-633-4227) and they can assist the individual with finding another pharmacy where they can receive their PrEP
  • Mail order pharmacies may be available
  • Teletypewriter (TTY) users can call 1-877-486-2048
• Pharmacies enrolled with Medicare Part B solely with a “mass immunization” provider type will need to enroll as a provider type “pharmacy” before they can bill Medicare Part B for HIV PrEP
• These same antiretroviral drugs may also be used for the treatment of HIV and (when using for treatment, not prevention) should continue to be billed to Medicare Part D
• For a patient with a Medicare Advantage plan, bill their Advantage plan (not their original Medicare Part B red/white/blue card) and watch the returned patient co-pay; if it is not $0, the pharmacy may not be contracted with the Advantage plan for medical billing (even if the pharmacy is contracted for pharmacy billing)
• PrEP claims which are 340B eligible do require a modifier on the claim, either “JG” (drug or biological acquired with 340B drug pricing discount, reported for information purposes) or “TB” (drug or biological acquired with 340B drug pricing discount, reported for information purposes for select entities); for more information on 340B modifiers, refer to the March 2023 Medicare Learning Network bullet